1. Field of the Invention
The present invention relates to human assay testing and tracking methods. More particularly, the invention relates to a system, method, and computer program that may be used to more quickly, accurately, and efficiently catalog, test, and track human assay samples and create documentation with respect to the human assay samples.
2. Description of the Prior Art
Drug testing collection facilities spend a considerable amount of time and money ordering, storing, filing, and indexing donors and clients and tracking the custody and control of specimens provided by donors. It is very important that no mistakes are made in collecting and tracking drug tests, such as mislabeling a specimen with the incorrect donor information. Therefore, drug testing collection facilities incur great expense and time to ensure that the custody and control of specimens is well-documented, correct, and forensically defensible.
Presently, most drug testing collection facilities manage specimen collection and tracking using mostly manual pen-and-paper methods. Since a majority of drug tests are performed at the request of an employer or potential employer of the donor, often for employment or pre-employment screening, a collection facility keeps a file of each employer's information and the tests they desire to be performed. The collection facility personnel then retrieves the employer's file, looks up the testing procedures the employer desires to be performed, and manually notes the selected information on a custody and control form (CCF).
Drug testing is often a regulated service, and thus, a CCF is required, or at least preferred, for each drug test a collection facility administers. A typical CCF will include the donor's name and other donor information, the employer's name and other employer information, the name of the collection facility and other collection facility information, including the name of the collector collecting the specimen, date and time of a specimen collection, and a unique identifier identifying the specimen, such as a barcode. The CCF may also include the tests to be performed on the specimen, the results of the tests, and other identifying information. The CCF usually has multiple copies, often as many as seven, so that the donor, collection facility, employer, Medical Review Officer (MRO), and lab(s) may each receive a copy. Although most forms are a carbonless type, not all copies contain the same information. For example, the donor's name and signature is often blocked out of certain copies for confidentiality. In many cases, results may be reported to the MRO but not to the collector. This requires that each individual or business in the process is mailed, faxed, or somehow forwarded their respective copy of the CCF, often at considerable expense. Additionally, each individual or business must then file and store their respective copy of the CCF, incurring personnel expense and wasting valuable storage space.
A CCF is necessary to document and track a specimen collection process. The most important item the CCF includes is a unique identifier, which identifies the specimen. A collection facility cannot complete a specimen collection until it has a unique identifier for the specimen. Therefore, the collection facility must have a CCF that contains a unique identifying label to be placed on the specimen and linking the specimen to the donor identified on the CCF. In practice, the collection facility does not collect the specimen until the collection facility has a CCF preprinted with the unique identifier, an employer's name, and a name of the MRO who will verify a positive lab result. Therefore, in order for the collection facility to open an employer's account, the collection facility commonly has CCFs for that employer preprinted with the above information.
A lab commonly supplies CCFs to the collection facility, and it is the lab which preprints the CCFs with the unique identifying label, the employer information, and the MRO's name. Once the lab preprints the CCFs, the lab then ships the forms to the collection facility or employer, which must store the forms until used. Due to the time necessary to request CCFs from the lab, wait for the lab to print each CCF with its respective employer information, MRO name, and unique identifier, and then ship the CCFs to the collection facility, it can often take six weeks or more to open a new account and preprint CCFs for an employer, tens of thousands in some cases. During this time, none of the employer's employees can be tested using the preprinted CCFs. Consequently, the process of opening an account or changing account information is unnecessarily time consuming and costly. Additionally, it is also common for each employer to have its own CCF, such that the collection facility must order and maintain separate CCFs for each employer, thus furthering the cost and time of the testing process and creating a burdensome storage problem for collectors. A change in form graphics, MRO name, or client information results in destroying thousands of unused forms. It is estimated that nearly fifty million paper CCFs, each two to seven parts, are used each year, while as many as twenty-five million are destroyed, discarded, or never used.
A procedural example of administering a human assay test begins with the donor producing a specimen, as is the case for a urine test. The collector must inspect the specimen for evidence of adulteration and note any signs of adulteration on the CCF. The collector then determines whether the specimen is within an acceptable temperature range and notes his or her findings on the CCF. The specimen is sealed and the bar code label, which is attached to the CCF, is peeled away from the CCF and affixed to the specimen container. The donor and collector sign the CCF, certifying that the information is correct, and the donor is dismissed. The collector then tests the specimen or prepares the specimen for shipment to a lab if the specimen is to be lab tested. Once received at the lab, the specimen and CCF are inspected and the information manually recorded on the CCF is manually entered by data entry personnel. The donor information, collector information, etc. are then transferred to the Laboratory Information Management System (LIMS) so that a laboratory report contains all the appropriate CCF identifying information.
Receipt of test results and marrying results to CCFs are the most problematic and inefficient steps in the drug testing process and occur after a results is reported. Turnaround time is often problematic and an important consideration because employers typically desire to receive the test results as soon as possible. A further problem of paper CCFs is the storage, filing, and indexing of the CCFs, and the delays in remarrying the CCF copy to the lab results for record-keeping purposes. This results in delays in reporting the tests results while the CCF is searched and married to the results. An employer must then be notified of the results via phone, facsimile, mail, or even e-mail.
Another problem presented by having a paper CCF is remote specimen collection. For example, if an employer desires to administer a test on a potential employee residing in Dallas, but the employer's primary place of business is in Kansas City, and consequently, the location of a collection facility that administers tests for the employer, then the employer must either transport the potential employee to Kansas City to produce a specimen, or the collection facility must mail a CCF to a collection facility in Dallas, so that a test can be administered and reported to the proper authorized contact. This process is time-consuming and expensive and could be remedied with the present invention.